BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3030466 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04465
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT# 267130002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. (B)(4). ANALYSIS OF THE NEUROSTIMULATOR MODEL 37702 SERIAL NKL717538H FOUND NO SIGNIFICANT ANOMALIES, THE INS WAS FUNCTIONALLY OK. ANALYSIS OF THE LEAD MODEL 39565-65 SERIAL (B)(4), FOUND CONDUCTORS BROKEN FROM OVERSTRESS / DAMAGE 6.5 CM FROM THE DISTAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. MANY REPROGRAMMINGS WERE ATTEMPTED WITHOUT RESOLUTION. IMPEDANCES WERE WITHIN NORMAL LIMITS AND X-RAY RESULTS WERE UNKNOWN. NO MALFUNCTIONS WERE SEEN AND THE ENTIRE SYSTEM WAS EXPLANTED. PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135117 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1